GENTECH archive 8.96-97

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John Fagan on the codex meeting



Date: 11 Apr 97 13:03:27 EDT
From: Peter Leadbetter <101370.1667@CompuServe.COM> To: Jim McNulty
<Jim@Niall7.demon.co.uk> Subject: CODEX ACTION PART 1


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From: John Fagan, INTERNET:jfagan@mum.edu TO:   John Fagan,
INTERNET:JFAGAN@CS1.MUM.EDU
DATE: 09/04/97 03:53

RE:     CODEX ACTION PART 1

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(John Fagan)
Subject: CODEX ACTION PART 1
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Dear Natural Law Party Leader,

The time is here for the next meeting of the Codex Alimentarus Committee on
Food Labeling (CCFL).

I am writing to ask for your help in moving this committee toward a
position on genetically engineered foods that will be more in tune with
Natural Law.

The decisions of the CCFL regarding food safety and labeling are very
influential, because Codex has been designated by the World Trade
Organization (WTO) as the rule-making body for all matters regarding import
and export of foods. In effect, in the international arena, Codex
regulations have the clout of international law, and can be backed up by
imposing trade sanctions and other serious penalties.

Because of this, we feel that it is very important to bring as much
attention and information to bear on the deliberations of this committee as
possible.

What you can do to help is to write a letter-either on behalf of the NLP of
your country, or as a private citizen, or both-to your Codex
representative. Please also ask others in your country to do the same. You
can find the name of your representative by accessing the following site on
the Web:
http://www.fao.org/waicent/faoinfo/economic/esn/nutri.htm

If you fax your letters to the Canadian NLP in Ottawa, those of us
attending the Codex meeting will personally hand deliver your letter along
with other supporting materials on the issue and on the NLP, to your
representative while they are attending the CCFL meeting. A stack of
letters from you and others, along with additional information on the issue
should have a powerful effect. Delivering this packet will also provide us
with an opportunity to interact with your representative directly, which
should also have a good influence. Please fax letters to 1 613 565 6546 or
1 613 565 1596. The meeting begins on the 14th and runs through the 18th,
therefore we have about one week to collect the necessary letters.

Attached you will find two examples of letters covering basic points on the
labeling issue as it applies to the Codex Committee on Food Labeling. Also
attached you will find a copy of my comments to the committee, and a copy
of an article that I have written on one of the central issues regarding
labeling-the concept of substantial equivalence. Please feel free to use
materials for your letter from any of these documents. I have also attached
a copy of the letter that we used in organizing a petition regarding the
Codex meeting last year. It has some good angles that you may find useful
for your letters and some good background on Codex.

I know that you are very busy, but I hope that you can find the time in the
next few days to send off a letter to Ottawa and to organize others to do
the same. You need not fax supporting documents, such as my comments and
article. We will have them in Ottawa and will provide them to your delegate
along with your letter.

Thank you again, and

Jai Guru Dev

John Fagan


Dear Codex Delegate:

I am writing to express my concern regarding developments within the CCFL
on the topic of the labeling of genetically engineered foods.

The recently released recommendations for the labeling of genetically
modified foods prepared by the Executive Committee of Codex are inadequate.
They do not address the safety issues related to labeling and they do not
take into account the critical issue of the consumer's right to know.

Before the 1996 meeting of the CCFL, several nations submitted comments
that called for labeling regulations that would allow consumers to make
informed decisions regarding the consumption of genetically engineered
foods. The arguments in support of such regulations were based on the
postential health risks of these foods, and on the consumers right to know.



This position is fully justified in light of considerable evidence
indicating that there are health risks associated with genetically modified
foods, and indicating that in all countries polled to date a significant
majority of consumers want to have genetically engineered foods labeled.
For instance a recent industry poll-by Novartis-showed that 93% of American
citizens strongly support the labeling of genetically modified foods. In
Europe recent polls indicate similar preferences. For instance, a poll by
Eurocommerce showed that 61% of consumers were unwilling to buy genetically
engineered vegetables.

In light of the strong demand from consumers for labeling, and in light of
the views expressed in 1996 by many representatives to the CCFL, the
position taken by the Executive Committee is highly suspect. Clearly,
industry pressure has prevailed within that less-than-open forum.

As the UK delegate to the CCFL, you are the official representative of the
British people in that forum. I am writing to ask you, as our
representative, to take a position on the labeling of genetically
engineered foods that will protect the welfare of British consumers, and
the welfare of your own family.

Attached you will find comments on the Executive Committee's
recommendations, by a scientist who has estensive knowledge and experience
in this area. These comments point out the inadequacies of the Committee's
position. Along with those comments you will find another article that
provides further information that may be useful in clarifying the issues
regarding labeling of genetically engineered foods.

I hope that you find these materials informative and useful.

Sincerely,


Dear Codex Delegate:

I have serious concerns regarding recent developments within the CCFL
regarding the labeling of genetically engineered foods. There are two
fundamental reasons for requiring that foods derived from genetically
engineered organisms be labeled as such.

First, people simply have the right to know what they are eating. If the
recently released recommendations by the Executive Committee of Codex on
labeling of genetically engineered foods (Codex Document CX?FL 97/7) are
implemented by the CCFL, our citizens will be deprived of that right.

The second reason that labeling should be required is that it is impossible
for genetic engineers to test for, and thus exclude, all possible harmful
effects of any given genetically engineered food. Thus, consumption of that
food carries with it a risk that is not associated with other foods. People
should be able to choose for themselves whether or not they wish to take
that risk. Accurate labeling makes it possible for them to make that
choice.

The undefined and undefinable nature of genetically engineered foods
derives from the fact that, even though genetic engineers can splice genes
with base-pair precision, they cannot predict accurately the effects of
modified genes on the organism into which they are inserted. As a
consequence, the nutritional value, the toxicity and the allergenicity of a
genetically engineered food cannot be predicted. Furthermore, once a
genetically engineered food is produced, it is not possible to carry out
sufficient safety testing to insure that it will be safe for all
individuals under all circumstances. This is the case for the simple reason
that safety testing cannot be that comprehensive.

For instance, tests may show that a genetically engineered food is free of
wide-spread toxic or allergenic effects, yet that food may still be toxic
or allergenic to a small portion of the population. Moreover, tests that
exclude gross toxicity or allergenicity are unlikely to detect low level
effects that, although not catastrophic to the consumer, might degrade
health or well-being somewhat. It would not be surprising to find, for
instance, that, since Bt toxin is deadly to some organisms, it might have
minor harmful effects for humans or for some segment of the population that
might already be compromised in some way (e.g. reduced levels of some
enzyme involved in Bt toxin degradation). As a consequence, foods derived
from plants that express the Bt toxin at high levels might have negative
effects on some people. Clearly the limited testing that is routine today
is not capable of eliminating such possibilities.

Accurate labeling allows people to know whether a particular food contains
novel components that are currently incompletely defined. People have the
right to such information. If genetically engineered foods turn out to be
as good for us as the biotech industry claims, such labeling will in the
final analysis be advantageous to the industry.

Please stand up for the welfare of consumers and support strong labeling
regulations for genetically modified foods.

Attached you will find comments on the Executive Committee's
recommendations, by a scientist who has estensive knowledge and experience
in this area. These comments point out the inadequacies of the Committee's
position. Along with those comments you will find another article that
provides further information that may be useful in clarifying the issues
regarding labeling of genetically engineered foods.

I hope that you find these materials useful.

Sincerely,

Comments on the Recommendations of the Executive Committee of the Codex
Alimentarius Commission Regarding the Labeling of Food Obtained through
Biotechnology

Natural Law Party
April 8, 1997

The recommendations of the Executive Committee of the Codex Alimentarius
Commission (Executive Committee) would appear to be a systematic attempt to
free the Codex Committee on Food Labeling (CCFL) from all substantive
responsibility regarding the labeling of genetically modified foods. In
paragraph 3 the Executive Committee eliminates considerations regarding
consumers right to know by claiming that calls for labeling on this basis
lie outside of the scope of the committee because decisions of the CCFL
should be based strictly on the four Statements of Principle concerning the
Role of Science.

In paragraph 22 the Executive Committee eliminates the need for CCFL to
consider the safety issues regarding genetically modified foods with the
following statement:
"...the essential principle of any food legislation is to ensure that foods
should not be available if they are not safe for consumption, whether
conventional or produced through biotechnology. Labelling should provide
the consumer with information on precautions for use if necessary, but
inherent safety of the product is a pre-requisite in any case."

On the basis of these laudable words, the Executive Committee directs the
CCFL to take as their starting point for defining regulations for labeling
of genetically modified foods the assumption that by definition, if a
genetically modified food product is on the market it must be safe, and
therefore that it will be unnecessary to consider the issue of food safety
in designing labeling regulations for genetically modified foods.

The Executive Committee then suggests revisions of the General Standard for
the Labeling of Prepackaged Foods that use the principle of substantial
equivalence as the basis for labeling and outlines revisions to the
standards that focus only on possible changes in composition or intended
use (eg preparation or handling procedures) in genetically modified foods.

We view this as an attempt to trivialize the issue of the introduction of
genetically modified foods into the global food market, and to avoid the
responsibility that Codex and particularly the CCFL rightfully have in
making sure that the entrance of these foods into the marketplace is
conducted in a manner consistent with scientifically-based safety
principles.

We further see this as yet another situation in which the larger
responsibility of Codex to protect the welfare of consumers has been
subordinated to the commercial interest in facilitating commerce.

We feel that the approach that the Executive Committee has taken is all
together inappropriate, and should be reconsidered.

The following are comments on specific aspects of the Executive Committee's
proposed amendments to the General Standard for the Labeling of Prepackaged
Foods:

1.      One highly questionable assumption underlies the Executive
Committee's recommendations, namely the assumption that, if a genetically
modified food is in the market place, it must be safe, and therefore that
it is unnecessary for CCFL to consider the issue of food safety in
designing labeling regulations for genetically modified foods. Their
confidence in the assumption that any food on the market will be safe is
borne out by the fact that the word safety does not appear even once in the
recommended revisions, nor does any other word of similar meaning.

Although this approach will greatly facilitate and accelerate the movement
of genetically modified foods from the laboratory into the global
marketplace, it leaves the consumer highly vulnerable to a new and
yet-not-fully-tested technology that is known to introduce health hazards
into foods.

To rectify this situation, we strongly recommend that food safety be
re-instated as a central and primary determinant of how genetically
modified foods will be labeled. This is only appropriate in light of the
mission of the CCFL, as described in various Codex documents.

Furthermore, instead of assuming that safety testing will take care of
itself, it is highly recommended that the CCFL organize a joint working
group with the Committee on Food Additives and Contaminants to develop an
integrated system of safety testing procedures and labeling regulations for
genetically modified foods that translate the outcome of safety assessment
research into labels that are informative to consumers.

2.      The revisions to the labeling standards that the Executive
Committee has proposed use the concept of substantial equivalence as the
basis for labeling. This is an inadequate approach.

Basing labeling of genetically modified foods on this concept is, in
essence, a strategy that further avoids the direct assessment of the safety
of genetically modified products. Moreover, it is even inadequate for
assessing nutritional value, handling characteristics, etc.

As is discussed in detail in "The failings of the principle of substantial
equivalence in regulating transgenic foods" (Fagan, J.B., Genetically
Modified Food Intelligence, Volume 2, December, 1996), one of the most
serious problems with the validity of the concept of substantial
equivalence is that the decision as to whether or not two things are
substantially equivalent is highly dependent on what characteristics are
compared.

For instance, by shrewdly selecting the parameters for comparison one could
generate data implying that zebras and tigers are substantially equivalent:
they both are warm blooded, both have fur, both have stripes, both have
teeth, eyes, four legs, etc. Clearly these two species are far from
equivalent, but clever selection of the parameters to be considered in
comparing them can lead to a conclusion of substantial equivalence.

The Executive Committee recommended that the selection of those parameters
should be on a case-by-case basis (paragraph 15), but did not recommend
clear-cut principles for guiding this selection. This creates huge
loopholes that leave developers of genetically altered foods with far too
much freedom to assure a reliable assessment of substantial equivalence,
and in addition it allows them to skirt the safety issue altogether.

2.      Beyond the problem of intentional manipulation in the selection of
characteristics to be considered in evaluating substantial equivalence,
this concept is based on fundamentally flawed reasoning.

The basic substantial equivalence argument goes along these lines: a.
Natural tomatoes are safe (demonstrated through long use as a food).
b.      We have measured 20 characteristics of natural and genetically
modified tomatoes and find no significant differences between the two with
regard to those 20 parameters.
c.      Therefore the genetically modified tomatoes are substantially
equivalent to the non-genetically engineered ones. d.   This means that (a)
their nutritional value is no different from
that of the corresponding non-genetically modified food, (b) their intended
use and handling characteristics are is no different from those of the
corresponding non-genetically modified food, and (c) they are as safe as
the corresponding non-genetically modified food.

It is a logical fallacy to claim that, just because 20 isolated
characteristics are similar in these two varieties of tomato, they are
equivalent in all substantive characteristics relevant to nutritional value
or intended use. Furthermore, findings of equivalence with regard to these
20 parameters do not imply that unmeasured characteristics related to
safety will be equivalent in these two varieties. We conclude that research
showing substantial equivalence is not adequate evidence for the safety of
a transgenic food or for the other calms listed in point d above.

The response of proponents is that in practice all important
characteristics of a food will be subjected to scruteny in assessing
substantial equivalence. Although this is an admirable goal, two factors
make this claim unrealistic. The first was discussed above, namely that
commercial developers will be left select for themselves which
characteristics will be part of the assessment of substantial equivalence,
and they will be highly motivated to select characteristics that support a
conclusion of substantial equivalence. The second factor is that it is
impossible to measure all important characteristics because we cannot know
them all. We do not have complete knowledge of human nutrition, immunology,
or toxicology, and we do not know all there is to know about the
biochemistry, physiology, etc. of food-producing organisms. Therefore we do
not have complete knowledge of the characteristics that might be important
in an analysis of substantial equivalence.

3.      This brings us to the most critical weakness in the substantial
equivalence approach. Namely, that this approach fails to detect unforeseen
safety hazards in a food. At best this approach can focus on known
characteristics that are suspected to be relevant to safety based on
experience with the corresponding non-genetically modified organism and on
knowledge of the organism from which the transgene is derived. For
instance, if a gene is transferred from peanuts to corn, it would be
logical, as part of the process of assessing substantial equivalence, to
determine whether the genetically modified corn displayed peanut
allergenicity.

However, as all molecular biologists will acknowledge, the process of
genetic engineering is inherently capable of introducing unanticipated
side-effects, and these can compromise the safety of a transgenic food in
unexpected ways. The substantial equivalence approach has no mechanism for
assessing such unexpected risks.

The process of genetic engineering-the process of introducing foreign
genetic material into the genome of an organism-can cause mutations to the
natural genes of that organism or alter the expression of such genes.
Moreover, the products of the transgene (a transgene is a gene introduced
into an organism by genetic engineering) may interact with other cellular
components in totally unexpected ways.

All of these mechanisms can lead to production of unforeseen toxins or
allergens in the transgenic food, or can lead to unanticipated alterations
in nutritional value. These problems are discussed in more detail in the
article, "The failings of the principle of substantial equivalence in
regulating transgenic foods," Fagan, J.B., Genetically Modified Food
Intelligence, Volume 2, December, 1996.

Given the complexity of the organisms from which we derive our food,
research aimed at assessing substantial equivalence will inevitably miss
unexpected changes due to genetic modifications. This is because such
research primarily uses in vitro tests that focus on isolated biochemical
or immunological characteristics, and because genetic modifications could
affect any one of thousands of different characteristics of the organism.
Therefore, it is highly unlikely that measurement of 20 or 40 or even 100
isolated parameters would detect those few characteristics that may be
unexpectedly altered through genetic modification. Thus a finding of
substantial equivalence is nearly meaningless with regard to such
unforeseen safety hazards.

The only scientifically valid approach to the problem of the safety of
genetically modified foods is to discard the concept of substantial
equivalence and carry out direct assessments of the safety of these foods.
The nature of the required testing is discussed in more detail in the
attached article ("The failings of the principle of substantial equivalence
in regulating transgenic foods" (Fagan, J.B., Genetically Modified Food
Intelligence, Volume 2, December, 1996). As explained in detail therein,
the essential component to a valid testing regime is clinical tests on paid
human volunteers. No series of in vitro tests, and no series of animal
studies will be adequate to establish safety. This is because neither in
vitro nor animal systems are fully valid model systems for evaluating
thoroughly and exhaustively all possible impacts of a food on the human
physiology.

4.      In paragraph 22 the Executive Committee discounts as inappropriate
the proposal that all genetically modified foods should be labeled as such.
Yet in the same paragraph the committee states that the essential principle
of any food legislation is to ensure foods should not be available if they
are not safe for consumption.

In light of the discussion above and in light of the article referenced
above, the risk is very real that any given genetically modified food may
pose health hazards to the consumer. Although research can be carried out
to assess whether a given transgenic food is in actuality harmful, no
safety testing regime is capable of categorically assuring 100% safety. For
instance, there is always the possibility that long term harmful effects
will surface that were not apparent in short term safety assessments. In
all cases, there is some residual risk associated with any genetically
modified food regardless how thoroughly it has been tested.

In light of this undeniable scientific fact, all foods produced through
genetic modification should be labeled as such so that consumers can choose
for themselves whether or not to accept the residual risk associated with
these foods.

5.      The recommendations of the Executive Committee deal only with
prepackaged foods. The risks of genetic modifications are not limited to
such products, but also extend to whole, unprocessed grains, legumes,
vegetables, fruits, etc. Thus revisions of food labeling standards should
include specific guidelines on how whole, unprocessed genetically modified
foods can be labeled to provide consumers with the information that they
need to make informed food purchases.

Prepared by
John B. Fagan, Ph.D.
Professor of Molecular Biology
Scientific Advisor to the Natural Law Parties

John B. Fagan, Ph.D.
Professor of Molecular Biology
Maharishi University of Management
(Maharishi International University 1971 to 1995) 1000 North Fourth Street
Fairfield, Iowa, 52557-1078
Phone(515) 472-8342
Fax (515) 472-5725
email jfagan@mum.edu